Category Archives: Drugs for Diabetes

Insulin Is Much Cheaper in Mexico

Great article by Robin Cressman. RTWT.

“Just a week before the trip [to Tijuana, Mexico], I was down to my very last vial of Humalog. It was June and I was close, but still so far, from hitting my $5,000 deductible for the year, which meant I was still paying full price out of pocket for all of my medical costs until I hit that figure. I had started the year low on supplies (a rookie mistake that I now know to avoid) and had been juggling bills from Dexcom, my doctor’s office, and my pump supplier for months, trying to only use our health savings account but often having to pull out credit cards to cover the costs. I called my pharmacy and asked to fill a single vial of Humalog, and the cost was $248.13. I hung up the phone. Instead I went to Walmart and for the first time bought vials of Novolin NPH and Regular for $24.99 each. It was those vials that were serving as my backup insulin a week later when I found myself in that pharmacy in Tijuana.”

Source: Crossing Borders to Afford Insulin – T1International

Whether it’s legal or not, I don’t know. I do think Big Pharma has made it illegal for me to go down to Mexico, buy a bunch of insulin, and sell it to my patients.

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Beware Fournier Gangrene If You Take an SGLT2 Inhibitor for Diabetes

The FDA is warning doctors about the possibility of Fournier Gangrene in folks taking a particular class of diabetes drug. This gangrene is a nasty infection that I’ve seen only a few times, always in men. The FDA reports cases in both men and women taking SGLT2 inhibitors.

“Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.”

Source: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes | FDA

Exercise and proper diet can reduce your need to take drugs for diabetes.

Click pic to purchase book at Amazon in the U.S.

Is There a Role for Magnesium Supplementation in Type 2 Diabetes?

Not the magnesium used in the study at hand

I hadn’t thought so until I read about an experiment published in 2003. Now I’m wondering.

The study was done in northern Mexico and all participants were taking glibenclamide, a sulfonylurea known as glyburide in the U.S. Importantly, study participants had low blood magnesium levels at the outset.

So if you’re not a hypomagnesemic Mexican taking glibenclamide, results may not apply to you.

Nevertheless, results were impressive. Compared to the control group, magnesium supplementation…

  • reduced insulin resistance
  • fasting glucose was 144 mg/dl (185 in controls)
  • Hemoglobin A1c was 8% (10% in controls)

The experiment lasted 16 weeks and the specific form of magnesium used was magnesium chloride solution.

Maybe we should be checking magnesium levels more often. BTW, magnesium supplements are difficult for our bodies to absorb. I know of at least three magnesium compounds: oxide, citrate, and chloride. There are probably others. Degree of absorption varies from one to the other. Adding a supplement on top of kidney impairment could cause toxicity.

The researchers conclude:

Oral supplementation with MgCl2 solution restores serum magnesium levels, improving insulin sensitivity and metabolic control in type 2 diabetic patients with decreased serum magnesium levels.

Source: Oral Magnesium Supplementation Improves Insulin Sensitivity and Metabolic Control in Type 2 Diabetic Subjects | Diabetes Care

 

Physician Organizations Fight Over How Aggressively to Treat Diabetes

If you’re a patient, you probably don’t like to hear this. You like to think that doctors have looked carefully at the appropriate scientific studies, understand  the underlying pathophysiology in detail, then reach a consensus on treatment. Sorry, but not in the case of diabetes. NPR has the story. For example:

A major medical association today suggested that doctors who treat people with Type 2 diabetes can set less aggressive blood sugar targets. But medical groups that specialize in diabetes sharply disagree.

Half a dozen medical groups have looked carefully at the best treatment guidelines for the 29 million Americans who have Type 2 diabetes and have come up with somewhat differing guidelines.

The American College of Physicians has reviewed those guidelines to provide its own recommendations, published in the Annals of Internal Medicine. It has decided that less stringent goals are appropriate for the key blood sugar test, called the A1C.

“There are harms associated with overzealous treatment or inappropriate treatment focused on A1C targets,” says Dr. Jack Ende, president of the ACP. “And for that reason, this is not the kind of situation where the college could just sit back and ignore things.”

The ACP, which represents internists, recommends that doctors aim for an A1C in the range of 7 to 8 percent, not the lower levels that other groups recommend.

Source: The American College of Physicians Recommends A1C Levels Between 7 And 8 Percent : Shots – Health News : NPR

I come down in favor of the lower HgbA1c values.

From 2012: Largest Healthcare Fraud Settlement In History Involves T2 Diabetes Drug Avandia

Your friendly neighborhood drug supplier

Your friendly neighborhood drug supplier

This will help you understand why I favor diet modification over drug therapy for type 2 diabetes:

“Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court. GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.”

Source: GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data | OPA | Department of Justice

Regarding Avandia:

“The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.”

And…

“In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.”

 

Are Some T2 Diabetes Drugs Better Than Others?

From MPT:

“The number of type 2 diabetes drugs that have a proven cardiovascular benefit jumped from one to three this year, highlighting the changing landscape for diabetes treatments.”

Source: Year in Review: Type 2 Diabetes | Medpage Today

The article notes that liraglutide (Victoza), a GLP-1 analogue, was associated with a 13% relative risk reduction in a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

Semaglutide, an experimental GLP-1 analogue, also has evidence for cardiovascular death prevention.

Another diabetes drug, Jardiance or empagliflozin, also has evidence for cardiovascular death prevention. Jardiance is an SGLT2 inhibitor.

Read the full MPT article for more details. I find the cost of these drugs to be an interesting yet little discussed detail.

Let’s assume these drugs actually reduce cardiovascular disease risk in T2 diabetics. What if they increase death and disease rates from cancer and infection? You don’t hear much about that, do you?

We still don’t know much about the long-term adverse effects of most of our diabetes drugs. That’s one reason I tend to favor diet modification as a primary diabetes treatment.

No degludec up in here!

FDA Says Jardiance Can Be Marketed as Cardiovascular Death-Defying

Jardiance is a diabetes drug in the class called SGLT2 inhibitors.

How do they work? Our kidneys filter glucose (sugar) out of our bloodstream, then reabsorb that glucose back into the bloodstream. SGLT2 inhibitors impair that reabsorption process, allowing some glucose to be excreted in our urine. You could call it a diuretic effect. For example, an SGLT 2 inhibitor called dapagliflozin, at a dose of 10 mg/day, causes the urinary loss of 70 grams of glucose daily.

How drugs like this could prevent cardiovascular disease in type 2 diabetics is a mystery to me.

From MPT:

“The diabetes drug empagliflozin (Jardiance) may be marketed for prevention of cardiovascular death in patients with type 2 diabetes and co-existing cardiovascular disease, the FDA said Friday.

It’s the first such claim ever allowed for a diabetes drug.

Empagliflozin, first approved in 2014, is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) pathway, reducing blood glucose by causing it to be excreted in urine.Its benefit for cardiovascular risk reduction was demonstrated in the so-called EMPA-REG trial, results of which were reported in 2015.”

Source: Jardiance Wins CV Prevention Indication | Medpage Today

Insulin cost in U.S. doubled between 2002-2013

This is NOT an insulin rig!

This is NOT an insulin rig!

You can’t blame inflation for the cost increase. I’m not sure the link below explains why.

Just this morning I was listening to AM “talk radio” and someone said her husband’s two insulins cost $1,400/month (USD). That’s ridiculous. He was between jobs and had lost his health insurance that had been paying for insulin.

If you’re worried about the cost of insulin, you can take action today to reduce your required dose: lose the excess weight, eat fewer carbohydrates, improve your insulin sensitivity with exercise.

From Reuters:

“The cost of the hormone insulin, one of the most important treatments for diabetes, rose nearly 200 percent between 2002 and 2013, according to a new study.

While other diabetes medications also increased in price, total spending on insulin in 2013 was greater than the combined spending on all those other drugs, researchers report in JAMA.

“The large increase in costs can largely be explained (by) much greater use of newer types of insulin known as analog insulins,” said senior author Philip Clarke, of the University of Melbourne in Australia. “While these drugs can be better for some patients, they are much more costly than the human insulin they replaced.”

Source: Insulin cost in U.S. more than doubles between 2002-2013 | Reuters

Steve Parker, M.D.

Study Finds No Survival Advantage for Eight Classes of Type 2 Diabetes Drugs

 

A waste of money?

A waste of money?

A multinational group of researchers tried to determine which drugs for type 2 diabetes were better at prolonging life and preventing cardiovascular deaths. They reviewed the existing literature (i.e., they did a meta-analysis of prior clinical studies.

There are no clear winners. Placebo worked as well as the eight drug classes examined!

Unfortunately, the abstract doesn’t say how long the clinical studies lasted, only mentioning that they were at least 24 weeks long. It’s quite possible it would take at least three to five years to see an effect on death rates.

Selected quotes:

“Eight different diabetes drug classes examined in a meta-analysis failed to demonstrate improved cardiovascular or all-cause mortality compared with placebo.Researchers analyzed 301 randomized clinical trials of patients with type 2 diabetes, and found that, metformin outperformed some other drug classes for its effect on hemoglobin A1c levels, there were no significant differences in mortality — including when placebo was included as a drug class.”

***

“A central finding in this meta-analysis was that despite more than 300 available clinical trials involving nearly 120,000 adults and 1.4 million patient-months of treatment, there was limited evidence that any glucose-lowering drug stratified by coexisting treatment prolonged life expectancy or prevented cardiovascular disease,” the authors wrote.”

***

“The authors wrote that their findings are consistent with guidelines from the American Diabetes Association, which — like the algorithm from the American Association of Clinical Endocrinologists — recommend that metformin monotherapy be used for the initial treatment of patients with type 2 diabetes. “Based on this review, clinicians and patients may prefer to avoid sulfonylureas or basal insulin for patients who wish to minimize hypoglycemia, choose GLP-1 receptor agonists when weight management is a priority, or consider SGLT-2 inhibitors based on their favorable combined safety and efficacy profile,” the authors wrote.”

Source: No Clear Survival Benefit Seen Among Diabetes Drugs | Medpage Today

Optimal Insulin Injection Guidelines from FITTER

Going in at a 45 degree angle with a 6 mm needle

Going in at a 45 degree angle with a 6 mm needle

“Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015.”

Source: New Insulin Delivery Recommendations – Mayo Clinic Proceedings

Here are some bullet points that most insulin users need to know:

  • Average skin thickness is 2 to 2.5 mm, with 90% of people under 3.25 mm.
  • Use the shortest needles: 6 mm for syringes, 4 mm for pen injectors. The short needles help you avoid injections into muscle. Injection into muscle increases risk of hypoglycemia and wide blood glucose excursions.
  • Acceptable injection sites: abdomen, thighs, buttocks, upper arms (usually on the back of the arm).
  • If an arm site is chosen with a 6 mm needle, inject into a lifted skin fold (otherwise you might hit muscle).
  • When using the 6 mm needle, inject into a lifted skinfold if you are a child or normal-weight adult. Alternatively, insert the needle at a 45 degree angle.
  • The preferred site for regular insulin (soluble human insulin) is the abdomen, for faster absorption.
  • Use needles only once. (Admittedly, many get away with multiple uses without much trouble.)
  • Don’t inject into lipohypertrophy areas. Lipohypertrophy eventually is an issue in half of insulin users. It is a localized area of swelling or lumpiness at the site of prior injections. It’s often easier to feel than to see. Injection into these areas causes erratic absorption of insulin, with potential widely fluctuating and unpredictable blood sugar levels.
  • Rotate injection sites to avoid lipohypertrophy.
  • If using cloudy insulins (e.g., NPH and some pre-mixed insulins), gently roll and tip the vial or pen until the solution is milk white.

Click here to read about…

  • How to roll and tip a vial to make cloudy insulin milk white.
  • Proper needle disposal.
  • Insulin infusion sets for continuous subcutaneous insulin injection via pumps.

Steve Parker, M.D.